EC nod for Kinpeygo for adults with primary IgA nephropathy

The European Commission (EC) has granted conditional marketing authorization for Kinpeygo (budesonide) for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.

The drug’s developer, Sweden’s Calliditas Therapeutics (STO: CALTX), saw its shares gain more htan 85 to 95.45 kroner following the announcement on Friday.

Kinpeygo is an orphan medicinal product and the first and only approved treatment for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need, with more than 50% of patients potentially progressing to end-stage renal disease (ESRD). Kinpeygo will be marketed in the European Economic Area (EEA) exclusively by Germany’s STADA Arzneimittel (SAZ: Xetra).